I.S. EN ISO 11607-1:2020&LC:2020
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Hardcopy , PDF
English
12-03-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials, preformed sterile barrier systems and sterile barrier systems
6 Design and development for packaging systems
7 Usability evaluation for aseptic presentation
8 Packaging system performance and stability
9 Packaging system validation and changes
10 Inspection immediately prior to aseptic presentation
11 Information to be provided
Annex A (informative) Guidance on medical packaging
Annex B (informative) Standardized test methods, guides and procedures that can be used to demonstrate conformity with the requirements of this document
Annex C (normative) Test method for resistance of impermeable materials to the passage of air
Annex D (informative) Environmental aspects
Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from protective packaging
Bibliography
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
| Committee |
CEN/TC 102
|
| DocumentType |
Test Method
|
| Pages |
64
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11607-1:2019 | Identical |
| EN ISO 11607-1:2020 | Identical |
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